Thyroid Biomarker Detection Device Using Segmented Flow Sections
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Solution Overview
Problem
Current diagnostic methods for thyroid medical conditions, such as differentiated thyroid cancer (DTC) and medullary thyroid carcinoma (MTC), face challenges including lack of standardization, interference from anti-Tg-antibodies, and the need for immediate thyroglobulin level measurement post-procedure, necessitating a point-of-care (POC) assay for rapid and accurate results.
Innovation Solution
A device comprising four sections: a sample collecting surface, a surface with probing molecules specific to thyroid biomarkers like thyroglobulin or calcitonin linked to reporter molecules, a surface functionalized with the biomarker, and a substrate molecule that generates a signal upon contact, allowing for lateral or longitudinal flow and enabling rapid diagnosis within minutes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If FNAWF-Tg measurement is performed using the same assay as serum Tg, then the measurement can be conducted with existing equipment and methods, but the results are not available during the FNA procedure and require dilution with saline
Solution Approach 1:
The device segments the measurement process into distinct functional sections: a sample collection section, a reaction section with probing molecules and reporter molecules, and a detection section with substrate molecules. This segmentation enables the measurement to be performed immediately on undiluted FNA washout fluid during the procedure itself, eliminating the time delay and dilution step while maintaining compatibility with existing measurement principles
Solution Approach 2:
The device introduces intermediary components including probing molecules that specifically bind to thyroglobulin, reporter molecules that generate triggers, and substrate molecules that produce detectable signals. These intermediaries enable rapid point-of-care measurement of FNAWF-Tg without requiring the same dilution and timing constraints as traditional serum Tg assays
2Productivity
If FNAWF-Tg is measured immediately following the procedure, then rapid diagnosis is achieved, but standardization in patient selection, biopsy technique, and analytical methods remains challenging
Solution Approach 1:
The device changes the analytical parameters by using a point-of-care format that measures Tg concentration directly in undiluted FNA washout fluid without requiring standardization of dilution volumes or timing. The assay is designed to accommodate varying sample conditions while maintaining measurement reliability, enabling rapid diagnosis without compromising standardization through built-in reference standards and controlled reaction conditions
3Loss of time
If a point of care assay is developed for rapid thyroid biomarker detection, then immediate results are available for timely treatment decisions, but the device complexity increases with multiple sections and molecules
Solution Approach 1:
The device merges multiple functions into an integrated point-of-care platform: sample collection, biomarker detection, signal generation, and result visualization are combined in a single handheld device with interconnected sections. This merging enables rapid thyroid biomarker detection within minutes while managing complexity through unified design and automated fluid handling between sections
Solution Approach 2:
The device employs a nested structure where section 2 (probing and reporter molecules) is functionally nested within the overall detection system, and section 4 (substrate molecules) provides the final signal output. This nested arrangement allows compact integration of multiple molecular layers and functional components in a space-efficient manner, reducing the physical footprint while maintaining the multi-step detection capability
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device provides rapid and sensitive detection of thyroid biomarkers, improving diagnostic accuracy and efficiency by allowing for on-site testing, reducing interference, and facilitating timely treatment decisions.
Implementation Method 1
a probing molecule having specific affinity to a biomarker of a thyroid medical condition
Implementation Method 2
the at least one probing molecule is linked to a reporter molecule capable of generating a trigger
Implementation Method 3
a substrate molecule capable of producing a signal upon contacting with the at least one reporter molecule
Implementation Method 4
sections 1 to 4 are in liquid communication allowing flow of liquid sequentially from sections 1 to 4
Data Source
AI summary
Disclosed is a device including at least 4 sections with a unique layout which includes a surface functionalized with an agent having specific binding affinity to a target molecule, and which allows flow. Disclosed are also a kit and a method for determining and quantifying the presence of a biomarker of a thyroid medical condition in a sample.